- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877459
Clinical Investigation of a Modified Staged Treatment Algorithm Using the AeriSeal System (STAGE)
A Multicenter, Prospective, Single-Arm Clinical Investigation of a Modified Staged Treatment Algorithm Using the AeriSeal System - the AeriSeal-STAGE Trial
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wien, Austria, 1140
- Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
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Berlin, Germany, 13353
- Charité Campus Virchow Klinikum (CVK)
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Heidelberg, Germany, 69126
- Thoraxklinik am Universitats klinikum Heidelberg
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Groningen, Netherlands, 9700 RB
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is willing and able to provide informed consent and to participate in the study
- Subject is ≥ 40 years of age
- Subject has a diagnosis of homogenous or heterogeneous upper lobe predominant emphysema confirmed by computerized tomography (CT) scan.
- Subject has at least two (2) non-adjacent subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
- Subject has clinically significant dyspnea scoring >1 on the mMRC scale of 0 - 4
- Subject has a Six-Minute Walk Test (6MWT) distance ≥ 250 meters
- Subject has post-bronchodilator FEV1 ≤ 45% predicted
- Subject has Total Lung Capacity >100% predicted
- Subject has Residual Volume >175% predicted
- Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhemoglobin or cotinine levels
- Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy
Exclusion Criteria:
- Subject has severe bullous emphysema as judged by Investigator.
- Subject has prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
- Subject has evidence of active respiratory infection
- Subject has an ongoing chronic obstructive pulmonary disease (COPD) exacerbation or bronchospasm
Subject has a known allergy to the device components:
- Polyether block amide - PEBAX®
- Polyvinyl Alcohol
- Glutaraldehyde
- Subject requires ventilatory support (invasive or non-invasive)
- Subject has diffusing capacity of the lungs for carbon monoxide (DLco) < 20% predicted
- Subject has a post-bronchodilator FEV1 < 20% predicted
- Subject cannot tolerate corticosteroids or relevant antibiotics
- Subject has relevant comorbidities as judged by the Investigator, or is deconditioned and cannot tolerate the stress of post-treatment inflammatory response
- Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalization during the year prior to enrollment
Subject has severe gas exchange abnormalities as defined by any one of the following:
- Partial pressure of arterial carbon dioxide (PaCO2) >55 mm Hg
- Partial pressure arterial oxygen (PaO2) <45 mm Hg on room air
- Peripheral capillary oxygen saturation (SpO2) < 90% on ≥ 4 L/min supplemental O2, at rest
- Subject has Pulmonary hypertension, defined as peak systolic pressure > 45 mm Hg on echocardiogram or right heart catheterization
- Subject use of systemic steroids >20 mg/day or equivalent and/or immunosuppressive agents in the 4 weeks prior to procedure
- Subject unable to temporarily interrupt use of heparins or oral anticoagulants (e.g., warfarin, dicumarol) per Institutional recommendations. Note: antiplatelet drugs including aspirin and clopidogrel are permitted
- Subject has alpha1 -antitrypsin serum level of <80 mg/kg (i.e. < 11 µmol/L) at Screening
Subject's CT scan indicates the presence of any the following radiologic abnormalities:
- Pulmonary nodule on CT scan greater than 0.8 cm in diameter [Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/positron emission tomography (PET)]
- Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
- Significant interstitial lung disease
- Significant pleural disease
- Subject's baseline electrocardiogram (EKG) indicates arrhythmias or conduction abnormalities
- Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines or ischemic heart disease, congestive heart failure, renal failure or cerebrovascular disease
- Clinically significant asthma (reversible airway obstruction), chronic bronchitis, or bronchiectasis
- Allergy or sensitivity to medications required to safely perform bronchoscopy and the AeriSeal System treatment under general anesthesia or conscious sedation
- Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the study or planned during the course of the study.
- Body mass index (BMI) < 15 kg/m2 or > 35 kg/m2
- Female subject pregnant or breast-feeding
Abnormal screening laboratory test results as compared to reference lab normals at individual sites as follows:
- Blood urea nitrogen > 1.5 x upper limit of normal
- Creatinine > 1.5 x upper limit of normal
- Aspartate aminotransferase > 1.5 x upper limit of normal
- Alanine aminotransferase > 1.5 x upper limit of normal
- Alkaline phosphatase > 1.5 x upper limit of normal
- White blood cells (total) absolute < 3 x 109/L or > 1.25 x upper limit of normal
- Hematocrit < 34 or > 1.25 x upper limit of normal
- Platelets < 100 or > 450 K/µL
- Prothrombin time or International Normalized Ratio (INR) > 1.5 x upper limit of normal
- Partial thromboplastin time > 1.5x upper limit of normal
- Positive Beta human chorionic gonadotropin (β-HCG) Pregnancy test (if female)
Subject has evidence of severe disease which in the judgment of the investigator may compromise survival for the duration of the study (24 months) e.g.:
- Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
- Active malignancy
- Stroke or Transient ischemic attack (TIA) within 12 months of Screening visit
- Myocardial infarction within 6 months of Screening visit
- Congestive heart failure within 6 months of Screening visit defined as clinical evidence of right or left heart failure or left ventricular ejection fraction < 45% on echocardiogram
- Subject has been diagnosed with diabetes mellitus
- Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject i.e., alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AeriSeal System
Subjects will be treated with AeriSeal Foam.
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Subjects will undergo two bronchoscopy procedures two months apart and will be treated with AeriSeal foam unilaterally, in two sub-segments during each bronchoscopy (4 segments treated in total).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of Serious Adverse Events
Time Frame: 3-months post treatment period
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Assessment of Serious Adverse Events (SAEs) To evaluate the safety of using a modified staged treatment algorithm at 3- months following the second placement of AeriSeal foam treatment in subjects with severe emphysema. The primary endpoint will be safety of AeriSeal System treatment. Safety will be assessed by monitoring the incidence of Serious Adverse Events (SAEs), during the 3-months post treatment period. Exclusively, the incidence of a prospectively specified subset of important respiratory related SAEs (COPD exacerbations requiring hospitalization or extended hospitalization, pneumonia, acute inflammatory response occurring after 30-days posttreatment, pneumothoraces), deaths and respiratory failures will be lower as compared to published data from prior studies. |
3-months post treatment period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Forced Expiratory Volume in one second (FEV1)
Time Frame: Baseline, 3-months, 6-months and 12-months
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Percent mean change relative to baseline at 3-months, 6-months and 12-months for FEV1
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Baseline, 3-months, 6-months and 12-months
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Residual volume (RV)
Time Frame: Baseline, 3-months, 6-months and 12-months
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Percent mean change relative to baseline at 3-months, 6-months and 12-months for RV
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Baseline, 3-months, 6-months and 12-months
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Exercise capacity as assessed by six-minute walk test (6MWT)
Time Frame: Baseline, 3-months, 6-months and 12-months
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Absolute change relative to baseline at 3-months, 6-months and 12-months for 6MWT
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Baseline, 3-months, 6-months and 12-months
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Quality of life as assessed by the St George's Respiratory Questionnaire (SGRQ)
Time Frame: Baseline, 3-months, 6-months and 12-months
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Absolute change relative to baseline at 3-months, 6-months and 12-months for SGRQ. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations. |
Baseline, 3-months, 6-months and 12-months
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Dyspnea as assessed by the Modified Medical Research Council Dyspnea Score (mMRC)
Time Frame: Baseline, 3-months, 6-months and 12-months
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Absolute change relative to baseline at 3-months, 6-months and 12-months for mMRC. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations. |
Baseline, 3-months, 6-months and 12-months
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Lobar volume reduction
Time Frame: 3-months
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Lobar volume reduction of the treated lobes as quantified by computerized tomography (CT) scans at 3-months
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3-months
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Radiological signs of complications on computerized tomography (CT) scans
Time Frame: 3-months following the second placement of AeriSeal foam.
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Radiological signs on CT scans of complications including but not limited to pneumonias, pleural effusions and consolidation at, and outside the treatment sites and formation of lung abscesses at 3-months following the second placement of AeriSeal foam.
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3-months following the second placement of AeriSeal foam.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Narinder Shargill, PhD, Pulmonx Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 630-0019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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